Ramping up global production of remdesivir, Gilead CEO Dan O’Day details plans to distribute 1.5M doses to fight Covid-19 — for free
Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.
In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.
They’re also not done. O’Day says that the company is building a global supply chain of raw materials and its production capacity — emphasizing the need for a global response to the pandemic that has spread like wildfire around the planet.
By this October, O’Day expects to have a half million courses ready, boosting that to a million by the end of the year.
Our efforts to increase supply continue with a strong sense of urgency. There is a long way to go and a lot of work to be done but I’m pleased that, despite the challenges we have been able to get supply levels to where they are today in a very short space of time – through the resourcefulness of our teams, creative approaches and collaboration.
O’Day recently confirmed the company’s development timeline, noting that the first data is expected this month. It will be one of the most closely-watched data readouts of the decade.
Geoffrey Porges at SVB Leerink believes Gilead could play a major role in addressing the coronavirus pandemic that has turned the world upside down in in the last month or 2.
Should remdesivir produce a 20-30% reduction in the mortality from COVID19, or improve other markers of clinical progression such as ventilator days or residual morbidity, then the community at large (worldwide) is likely to breath a huge sigh of relief at the prospect of making this disease more manageable medically and economically. The news from the first trials of remdesivir is likely to be disclosed this week, and could be a major catalyst for a change in sentiment in equity markets should the drug be effective.
Gilead has become something of a lightning rod during the pandemic, with one of the most advanced therapies in the clinic. Its move to gain an orphan drug designation for remdesivir was roasted by consumer advocates, who saw it as an attempt to unfairly profit off the crisis. And O’Day quickly backed away, dropping the market incentives that the FDA offers for rare disease drugs.
Gilead has repeatedly been singled out over the years for its pricing practices, drawing the ire of AIDS advocates and more recently astounding payers with their initial sticker price on a painless cure for hep C that quickly earned a fortune — and just as quickly melted away as the drug worked as billed.
In setting course for initially distributing large amounts of the drug for free, Gilead now has a chance to reform its image while helping set the course for others to follow.
Gilead recently backed away from providing the drug for individual compassionate use requests after getting inundated with pleas. And the same day O’Day was posting his open letter, officials at the EMA were urging Gilead to fairly distribute the drug in the EU.
“Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but the CHMP acknowledges the need for a harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials”, said Harald Enzmann, the chair of the CHMP. “The CHMP encourages the company to make remdesivir available in a fair and transparent way to those Member States wishing to take part in international clinical trials or treat patients in compassionate use programmes.”